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Supervising people is the toughest of all leadership roles.

Supervisors in many organisations walk a tightrope between management demands for higher productivity, a safer work

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

place and improved customer satisfaction and the demands of workers for higher pay, better conditions and a say in how the work is designed and executed.

Supervisors have to p

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

lan, instruct, coach, counsel, report, negotiate and prioritise, often with little authority.

Good supervisors should make good managers without much help. The skills they hav

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e stand them in good stead for management. Right?

Except for a few financial skills and strategic skills which they will pick up on the job and with some judicious use of the

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

raining budget, they are ready made to move to management. Surely?

Wrong.

The transition from supervisor to manager is hard. Supervisors transitioning to management roles hav

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e a steep learning curve in soft and hard skills.

Most supervisory positions have targets set by their manager in consultation with the supervisor, but set by the manager. Sup

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ervisors have the vision, mission and values of the organisation set by others. Supervisors have the policies, and in most cases, a large majority of the processes designed by

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

others.

Supervisors operate within a set of boundaries given to them by others.

Supervisors tend to have a bond with the people that work for them. They see each other every

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ay spending hours in each other's company, building rapport and respect if the supervisor is a good one worthy of promotion.

When a supervisor becomes a manger of teams of peo

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ple rather than a team, they become accountable for many of the elements of management for which they were previously only responsible.

They have to design processes for plann

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ing the next year's marketing, sales or operating budget. In some cases, they do all three. They have to make decisions on which of several good ideas will make the cut in the

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

budget process.

They have to make judgements about the future worth and development requirements of subordinates who may have been their peers until recently.

In both of the

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

bove cases they have to communicate news that may disappoint in such a manner as to be clear and yet empathetic and not fall into the trap of being sympathetic.

They have to b

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ecome part of a team that relies on reports and feedback from others to "see" what is happening on-the-ground rather than seeing it with their own eyes. They become p

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

art of a team which does not see each other constantly but needs rapport as much as the team from which they were promoted.

Much of their authority within the team they have n

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ow joined comes from an ability to influence, not simply an authority schedule. Politics is much more prevalent and they have to deal with more hidden personal agendas.

In man

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

cases their technical expertise is less valued. In all senses they go from being the big fish in the small pond to the small fish in the big pond.

In the organisations that I

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

have worked in or been associated with, only a handful provide "Introduction to Management" training for their new managers who have been promoted from supervisory l

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

evel. Yet the transition is no less daunting then the first days of being in a new organisation. At least then most organisations provide induction training.

Supervisors who a

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

re promoted to managerial tasks need help. Organisations should give that help by way of training and by way of appointment of a mentor to guide them through the learning curve

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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